The Recall Desk
SevereFDA (Drugs)·D-0532-2016·Announced 2016-01-06

Walgreens Recalls Primaxin Infusion Minibags Due to Sterility Concerns

Walgreens Infusion Services is recalling 40 minibags of Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL due to a lack of assurance of sterility. The affected products were distributed in Texas.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an intravenous medication, which poses a risk of serious infection or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

Walgreens Infusion Services is voluntarily recalling 40 minibags of Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL. The product is compounded by Option Care 148 in San Antonio, Texas, and is available by prescription only. The recall is being conducted because of a lack of assurance of sterility.

The affected units are all lots within their expiry dates. The distribution pattern for this recall is limited to Texas. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers who have purchased or received these specific minibags should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product
Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Affected units
40

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots within expiry.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 33 recalled by Walgreens Infusion Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 33 products in this recall →